The fields of interventional radiology, vascular surgery and cardiology require the removal of clots in the arterial and venous systems to reduce the complications arising from vascular occlusions. Additionally, thrombosis of hemodialysis access grafts/fistulae are common issues that dialysis patient's encounter and must be addressed. Specifically, in the case of deep vein thrombosis (DVT), a disease state in which a patient presents with a blood clot in a peripheral vein, the clot may be removed to resolve the patient's acute symptoms, or to help prevent complications of the DVT, including valve damage, Post Thrombotic Syndrome or embolization/migration of clot to the lung, a potentially fatal condition called pulmonary embolism (pulmonary artery occlusion). These clots are typically removed via surgical, pharmacological, or minimally invasive mechanical or pharmacomechanical means. Techniques used for treatment of the clot include injecting/infusing a thrombolytic agent, tissue plasminogen activator (tPA), into the clot to help dissolve the clot, or alternative methods which involve mechanical removal of the clot using aspiration catheters, rotational baskets or other mechanical maceration devices.
The limitation of these devices include the systemic risks of lytic agent infusion, non-control of mobile clots during removal, inability to adapt to anatomical variations, incomplete thrombus removal by inability to gain wall to wall apposition, bradycardia and hemoglobinuria during rheolysis, hemolysis and vein or arterial wall damage resulting from mechanical removal means. Therefore, a need exists for an improved clot removal device for patients experiencing vascular thrombosis, pulmonary embolism, hemodialysis graft thrombosis and arterial thrombosis.